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Cellular Therapies and Clinical Trials in Canada

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Cellular Therapies Manufacturing and Clinical Trials in Canada

Date and Location:

 

October 29-31, 2014

Fairmont Chateau Laurier 

Ottawa, Ontario (site of the 2014 Till and McCulloch Meetings. Click here to register.)

 

Introduction:

 

Cellular therapies provide exciting new opportunities to improve human health and treat diseases. In order to realize the power of using cells as therapeutic tools, it is necessary to navigate the often daunting regulatory process of clinical trials and approval. As many therapies require large numbers of cells, consideration must also be given as to how they will be manufactured. Both aspects go hand-in-hand in the delivery of a safe, efficacious, and cost-effective therapy.

 

Description and Workshop Agenda:

 

This workshop combines lectures, case studies and demonstrations to facilitate an appreciation of the multiple aspects of conducting clinical trials in Canada including preclinical studies, quality control and regulatory approval, as well as basic cellular manufacturing principles. Learn from the experiences of national and international leaders in the field. Network with other investigators. Interact with representatives from Health Canada’s Biologics and Genetic Therapies Directorate. Get hands-on with some of the latest cell manufacturing technologies.

 

Please find a DRAFT agenda below. 

 

Day 1 - Oct 29th

Session

Speakers

18:00:18:15

Welcome

 

18:15-21:00

Dinner/presentation/networking

(presentation on convergence of bioprocessing  solutions for cell therapy manufacturing and protein production)

Nick Timmins, CCRM

Sowmya Viswanathan, University Health Network/CCRM

 

Day 2 – Oct 30th

Session

Speakers

08:30-10:00

Clinical Trials

Duncan Stewart, Ottawa Hospital Research Institute

David Courtman, Ottawa Hospital Research Institute

10:00-10:30

Coffee break

 

10:30-11:30

Canadian Regulatory Perspective

Francisca Agbanyo, Health Canada

11:30-12:30

Harvest/Downstream Processing

Brian Murphy, Celgene

12:30-14:00

Lunch (interactive with sponsors)

 

14:00-15:00

Wash/Preservation/Shipment 

Ben Fryer, Betalogics

15:00-16:00

Preservation Solutions

Aby Mathew, BioLife Solutions

16:00-16:30

Coffee break

 

16:30-18:30

Group work (case studies)

 

18:30-21:00

Dinner and activities

 

Day 3 – Oct 31th

Session

Speakers

8:30-9:30

RUO to Regulatory Compliant Culture Media - The Road to Approval

Lynn Csontos, STEMCELL Technologies

Erik Hadley, STEMCELL Technologies

9:30-11:30

Case study presentations and discussion with panelists 

 

  Wrap-up / boxed-lunch to go  


Registration and Application, Fees and Deadlines:

$500: Academic (Student or PI)

$500: CCRM Industry Consortium Member

$750: Industry 

 

CCRM has booked a block of rooms at the Fairmont Château Laurier at a rate of $209/night.  If you would like to book a room at the Fairmont, please call their Global Reservations Centre at 1-800-441-1414 and quote the "CCRM Cellular Therapies Workshop" or you can book online at https://resweb.passkey.com/go/ccrm2014. The rate is valid from Sunday, October 26 to Monday, November 3, 2014. If you are attending the Till & McCulloch meetings and are staying at the Westin Hotel, you are welcome to extend your stay there, as it is only a 5-minute walk to the Fairmont. If you have any questions, please don’t hesitate to contact Marion Sweeney at marion.sweeney@ccrm.ca or 1.416.978.3751.

 

 

Financial support is available to eligible participants through the Stem Cell Network (SCN) here.

For sponsorship or questions, contact us at: info@ccrm.ca 

 

Workshop Leaders:

 

Cellular Therapies Manufacturing and Clinical Trials in Canada is led by Drs. Sowmya Viswanathan, Cell Therapy Program, University Health Network (UHN) and consultant CCRM, and Nick Timmins, CCRM.